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Health Canada Health products

BEOVU (brolucizumab) – Risk of Intraocular Inflammation, Retinal Vasculitis and/or Retinal Vascular Occlusion

Issued February 3, 2022
Issue
An increased incidence of intraocular inflammation (IOI), including retinal vasculitis (RV) and retinal vascular occlusion (RO), was observed in patients who received BEOVU 6 mg with every 4 weeks (q4 week) dosing beyond the first 3 doses compared to aflibercept 2 mg every 4 weeks, in neovascular age-related macular degeneration (nAMD) in the MERLIN study. A causal link was observed between the treatment-emergent immune reaction against BEOVU and the BEOVU related “retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation” ( BASICHR0049 study).
Hazard description
New safety information - Product safety
Product
Product name
BEOVU (brolucizumab)
Reference
ID
RA-63879